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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Elastomeric
510(k) Number K972158
Device Name GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
Applicant
Princeton Regulatory Assoc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Applicant Contact THOMAS BECZE
Correspondent
Princeton Regulatory Assoc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Correspondent Contact THOMAS BECZE
Regulation Number880.5725
Classification Product Code
MEB  
Date Received06/09/1997
Decision Date 02/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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